Izzhogoff^® (Tablets) Instructions for Use

Marketing Authorization Holder

Evalar, CJSC (Russia)

Contact Information

EVALAR JSC (Russia)

ATC Code

A02AX (Antacids in combination with other agents)

Active Substances

Calcium carbonate (Ph.Eur. European Pharmacopoeia)

Magnesium carbonate (Ph.Eur. European Pharmacopoeia)

Dosage Form

Izzhogoff®

Chewable tablets [mint] 680 mg+80 mg: 12 or 24 pcs.

Dosage Form, Packaging, and Composition

Chewable tablets [mint] oval, biconvex, white or almost white, with a mint odor.

Excipients: sorbitol – 369.5 mg, corn pregelatinized starch, potato starch, maltodextrin, talc, magnesium stearate, natural flavor “Mint”, sodium saccharin – 0.80 mg.

12 pcs. – blister packs (1) – cardboard packs.
12 pcs. – blister packs (2) – cardboard packs.

Clinical-Pharmacological Group

Antacid drug

Pharmacotherapeutic Group

Acid-related disorder treatment agents; antacids; antacids, other combinations

Pharmacological Action

The Izzhogoff^® tablet contains antacid substances – Calcium Carbonate and Magnesium carbonate, which provide rapid and prolonged neutralization of excess hydrochloric acid in gastric juice, thereby exerting a protective effect on the gastric mucosa.

The rapid achievement of a positive effect is due to the good solubility of the tablets and the high content of calcium carbonate. Calcium Carbonate has a rapid, prolonged, and strong neutralizing action. This effect is enhanced in the presence of magnesium carbonate, which also has a strong neutralizing action.

In vitro acid neutralization studies (artificial stomach model) showed that Izzhogoff^® increases gastric pH from 1.5-2 to 3 within 40 seconds and can reach a pH value of 4 in 1 minute 13 seconds. The maximum pH level achieved in the model test was 5.24.

Pharmacokinetics

Absorption

As a result of the interaction of Izzhogoff^® with gastric juice, soluble calcium and magnesium salts are formed in the stomach. The degree of absorption of calcium and magnesium from these compounds depends on the dose of the drug. Maximum absorption is 10% for calcium and 15-20% for magnesium.

In case of impaired renal function, the plasma concentration of calcium and magnesium may increase.

Excretion

A small amount of absorbed calcium and magnesium is excreted by the kidneys. In the intestine, insoluble compounds are formed from soluble salts, which are excreted in the feces.

Indications

For adults and children over 12 years of age to relieve symptoms associated with increased acidity of gastric juice and reflux esophagitis

• Heartburn;
• Sour belching;
• Occasional stomach pain;
• Feeling of fullness or heaviness in the epigastric region;
• Dyspepsia (including that caused by dietary errors, medication use, alcohol, coffee, or nicotine abuse);
• Dyspepsia of pregnancy.

ICD codes

Dosage Regimen

Orally. Chew or hold in the mouth until completely dissolved.

Adults

1-2 tablets to chew (or hold in the mouth until completely dissolved) when symptoms appear, unless otherwise recommended by a doctor. If necessary, the drug can be repeated after 2 hours.

The maximum daily dose is 11 tablets.

Without a doctor’s instruction, the maximum daily dose of calcium carbonate equal to 8 g (corresponding to 11 tablets of Izzhogoff^®) should not be exceeded, or the drug should not be used at the maximum daily dose continuously for more than 2 weeks.

Children

The dosage regimen for children aged 12 years and older does not differ from the dosage regimen for adults.

Izzhogoff^® is contraindicated for use in children under 12 years of age.

Adverse Reactions

The listed adverse drug reactions are based on spontaneous reports, so their classification according to the MedDRA III frequency categories is not applicable.

Immune system disorders very rarely – hypersensitivity reactions, including rash, urticaria, itching, angioedema, dyspnea, and anaphylaxis.

Metabolism and nutrition disorders long-term use of the drug in high doses may lead to hypermagnesemia or hypercalcemia and alkalosis, especially in patients with renal failure.

Gastrointestinal disorders nausea, vomiting, stomach discomfort, constipation, and diarrhea may occur in predisposed patients.

Musculoskeletal and connective tissue disorders muscle weakness may occur.

Drug overdose may lead to the formation of milk-alkali syndrome, including the following manifestations

Gastrointestinal disorders loss of taste.

Nervous system disorders headaches.

Renal and urinary disorders azotemia.

General disorders and administration site conditions calcification and asthenia.

Contraindications

• Hypersensitivity to the active substance or to any of the excipients included in the drug;
• Severe renal failure;
• Hypercalcemia;
• Hypophosphatemia;
• Nephrocalcinosis;
• Rare hereditary fructose intolerance;
• Children under 12 years of age.

With caution:

• Pregnancy;
• Breastfeeding period;
• Children under 18 years of age.

Use in Pregnancy and Lactation

Pregnancy

When used in recommended doses, the drug does not pose a danger to the fetus. To prevent the intake of excess calcium, pregnant women should avoid concomitant excessive consumption of milk and dairy products.

Breastfeeding period

The use of the drug during breastfeeding in recommended doses does not pose a danger to the child.

Fertility

Data on possible influence are absent.

Use in Renal Impairment

In case of impaired renal function, the plasma concentration of calcium and magnesium may increase.

Contraindicated in severe renal failure.

Pediatric Use

Contraindicated for use in children under 12 years of age.

Use with caution in children and adolescents from 12 to 18 years of age.

Special Precautions

Prolonged use of the drug and exceeding the indicated dose should be avoided. If symptoms persist or only partially disappear, it is necessary to consult a doctor.

When prescribing the drug to patients with impaired renal function, the concentration of magnesium, phosphorus, and calcium in the blood serum should be regularly monitored.

Patients with impaired renal function are not recommended to take the drug for a long time in high doses. The use of Izzhogoff^® in high doses may increase the risk of kidney stone formation and development.

Long-term use of the drug in high doses may lead to adverse reactions such as hypercalcemia, hypermagnesemia, and milk-alkali syndrome, especially in patients with renal failure.

This drug should not be taken with large amounts of milk or dairy products. Prolonged use of this drug with these products increases the risk of kidney stones.

Excipients

Note for diabetic patients: 1 Izzhogoff^® tablet contains 369.50 mg of sorbitol and can be used by patients with diabetes mellitus.

This drug contains less than 23 mg of sodium per 1 tablet in the 680 mg+80 mg dosage, i.e., it is essentially sodium-free.

Patients with rare hereditary fructose intolerance should not take this medicine because it contains sorbitol. Sorbitol may have a mild laxative effect.

Effect on ability to drive vehicles and operate machinery

Izzhogoff^® does not affect the ability to drive vehicles and operate machinery.

Overdose

Symptoms long-term use of the drug in high doses in patients with impaired renal function may lead to renal failure, may cause hypermagnesemia, hypercalcemia, alkalosis, which may manifest as nausea, vomiting, muscle weakness.

Treatment administration of the drug should be discontinued and adequate fluid intake should be ensured. In serious cases of overdose (e.g., milk-alkali syndrome), a doctor should be consulted, as other rehydration measures (e.g., infusions) may be required.

Drug Interactions

Changes in gastric juice acidity during the use of antacids may lead to a decrease in the rate and extent of absorption of other drugs when taken simultaneously, therefore medicinal products should be taken 1-2 hours before or after taking antacid drugs.

Tetracycline antibiotics, fluoroquinolones, cardiac glycosides, levothyroxine, iron preparations, fluorides, phosphates – when used concomitantly, antacids reduce the absorption of these drugs.

Thiazide diuretics – when taken concomitantly with antacids, serum calcium concentration should be regularly monitored.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

The shelf life is 3 years. Do not use after the expiration date.

Dispensing Status

The drug is available without a prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.